Authorizes $6.7 Million to Fund Diabetes Research through New Collaborative Initiative with CDC and NIH
WASHINGTON, D.C. (Jan. 26, 2016) — The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved $70 million for nine new patient-centered research projects focused on conditions ranging from ductal carcinoma in situ (DCIS), a very early stage, localized type of breast cancer to diabetes, chronic lung disease, and migraines. With these latest awards, PCORI has now approved or awarded more than $1.2 billion in research funding.
Five of the awards are the latest in PCORI's initiative to support "pragmatic clinical studies." These studies aim to produce results that are more relevant to a broad range of patients and care settings and easier to adopt in routine practice. They are conducted in routine clinical settings, rather than in specialized research centers, and involve participants who more closely mirror typical patients.
The newly approved pragmatic studies will compare:
- Active surveillance versus traditional treatment options, such as surgery and radiation, for patients diagnosed with DCIS.
- The effectiveness of two medications – roflumilast and azithromycin – commonly used to treat patients with chronic obstructive pulmonary disease (COPD).
- The effectiveness of different approaches involving community health workers, tailored education, and other means to help adults with serious mental illness quit smoking.
- The effectiveness of daily use of an inhaled corticosteroid versus symptom-based use for reducing asthma exacerbations in African American and Hispanic adults with asthma.
- The effectiveness of two approaches to help people manage their chronic migraines and reduce the risk medication overuse.
"We're strongly committed to supporting large-scale projects that will provide patients and those who care for them with the useful, authoritative evidence they need to make the better-informed health and health care decisions," said PCORI Executive Director Joe Selby, MD, MPH.
Each study will involve national advocacy organizations, major professional societies and associations, payers, and other key patient and stakeholder groups, in their research design and implementation. This kind of engagement can facilitate quicker dissemination and application of study results.
In addition, the Board approved $6.7 million in awards to three of the Clinical Data Research Networks (CDRNs) that are members of PCORnet, PCORI’s initiative to develop a national patient-centered clinical research network. The awards will help the recipients study the impact of population-targeted health policies and interventions on risks, complications and disparities related to type II diabetes.
Their projects will be part of the newly announced Natural Experiments Network (NEN), a joint effort of PCORI, the U.S. Centers for Disease Control and Prevention, and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health. NEN study findings are meant to inform policy makers’, health plan directors’ and community leaders’ efforts to prioritize policies and other actions to prevent diabetes. View the three awarded projects.
The Board also approved $5.2 million for a study that addresses PCORI’s priority to fund research on improving healthcare systems. This study will determine whether encouraging text messages or working with diabetes wellness coaches is more effective at helping of African Americans with uncontrolled diabetes manage their conditions. View this awarded project
In addition, the Board authorized a supplemental $3.8 million in funding for the ADAPTABLE trial, a PCORnet study that aims to identify the optimal dose of aspirin to prevent heart attacks and strokes in patients with heart disease. The funds will support expanded trial activities, including the participation of two additional CDRNs as well as recruiting patients with no Internet access, an important subpopulation given the study’s reliance on digital tools.
All of the new awards were approved pending a business and programmatic review by PCORI staff and issuance of formal award contracts. PCORI has now approved or awarded $912 million for 292 comparative clinical effectiveness research (CER) projects that will provide evidence to help patients and those who care for them make better-informed healthcare choices. In addition, PCORI has awarded $101 million to support 122 projects on improving the methodology for conducting rigorous patient-centered outcomes research and has invested $235 million to fund the development of PCORnet, a national clinical research network designed to enable patient-centered clinical research to be conducted more efficiently than previously possible.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.